Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Male and Female Acne: Phase 3 Analysis.

IF 1.5 4区医学 Q3 DERMATOLOGY

Journal of Drugs in Dermatology Pub Date : 2024-10-01 DOI:10.36849/JDD.2024.8484

Edward Ted Lain, Neal Bhatia, Leon Kircik, Linda Stein Gold, Julie C Harper, Christopher G Bunick, Eric Guenin, Hilary Baldwin, Steven R Feldman, James Q Del Rosso

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引用次数: 0

Abstract

Background: Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel (CAB) is the only fixed-dose triple-combination treatment approved for acne. This post hoc analysis assessed the impact of sex on efficacy and safety/tolerability of CAB.

Methods: In two multicenter, double-blind, phase 3 studies (NCT04214639 and NCT04214652), participants aged ≥9 years with moderate-to-severe acne were randomized (2:1) to 12 weeks of once-daily treatment with CAB or vehicle gel. Pooled data were analyzed by sex. Assessments included treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and a score of 0 [clear] or 1 [almost clear]), inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability.

Results: At week 12, treatment success rates were significantly greater with CAB versus vehicle irrespective of sex (females: 53.7% vs 23.0%; males: 43.1% vs 24.6%; P<0.05, both). CAB-treated female and male participants both experienced greater reductions from baseline versus vehicle in inflammatory (females: 77.7% vs 57.9%; males: 77.5% vs 57.1%; P<0.001, both) and noninflammatory lesions (females: 72.5% vs 45.6%; males: 72.3% vs 49.6%; P<0.001, both). Acne-QoL improvements from baseline to week 12 were significantly greater with CAB than vehicle. No significant differences in any efficacy measures between CAB-treated males and females were observed. Most TEAEs were of mild-to-moderate severity; no sex-based trends for safety/tolerability were observed.

Conclusions: CAB demonstrated comparable efficacy, quality-of-life improvements, and safety in female and male participants with moderate-to-severe acne. As the first fixed-dose, triple-combination topical formulation, CAB represents an important new treatment for acne. J Drugs Dermatol. 2024;23(10):873-881. doi:10.36849/JDD.8484.

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治疗男性和女性痤疮的克林霉素磷酸酯 1.2%/阿达帕林 0.15%/过氧化苯甲酰 3.1%凝胶：第 3 阶段分析。

背景：克林霉素磷酸酯1.2%/阿达帕林0.15%/过氧化苯甲酰3.1%凝胶（CAB）是唯一获准用于治疗痤疮的固定剂量三联疗法。这项事后分析评估了性别对 CAB 疗效和安全性/耐受性的影响：在两项多中心、双盲、3期研究（NCT04214639和NCT04214652）中，年龄为9岁、患有中度至重度痤疮的参与者被随机（2:1）安排接受为期12周、每天一次的CAB或载体凝胶治疗。汇总数据按性别进行分析。评估包括治疗成功率（评估者总体严重程度评分比基线降低2级，0分[痊愈]或1分[基本痊愈]）、炎性/非炎性皮损计数、痤疮生活质量（Acne-QoL）问卷、治疗突发不良事件（TEAEs）以及皮肤安全性/耐受性：第12周时，不论性别，CAB治疗成功率明显高于药物治疗成功率（女性：53.7% vs 23.0%；男性：43.1% vs 24.6%；P<0.05，均为P<0.05）。接受过 CAB 治疗的女性和男性参与者的炎症性皮损（女性：77.7% vs 57.9%；男性：77.5% vs 57.1%；P<0.001，均为）和非炎症性皮损（女性：72.5% vs 45.6%；男性：72.3% vs 49.6%；P<0.001，均为）均较基线时有更大的减少（女性：77.7% vs 57.9%；男性：77.5% vs 57.1%；P<0.001，均为）。从基线到第 12 周，CAB 对痤疮生活质量的改善明显大于药物。接受过CAB治疗的男性和女性在任何疗效指标上都没有明显差异。大多数TEAE的严重程度为轻度至中度；在安全性/耐受性方面没有观察到基于性别的趋势：结论：CAB对中重度痤疮患者的疗效、生活质量改善和安全性具有可比性。作为首个固定剂量、三合一外用制剂，CAB是治疗痤疮的重要新疗法。J Drugs Dermatol.2024;23(10):873-881. doi:10.36849/JDD.8484.

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来源期刊

Journal of Drugs in Dermatology DERMATOLOGY-

CiteScore

2.20

自引率

13.30%

发文量

289

审稿时长

3-6 weeks

期刊介绍： The Journal of Drugs in Dermatology (JDD) is a peer-reviewed publication indexed with MEDLINE®/PubMed® that was founded by the renowned Dr. Perry Robins MD. Founded in 2002, it offers one of the fastest routes to disseminate dermatologic information and is considered the fastest growing publication in dermatology. We present original articles, award-winning case reports, and timely features pertaining to new methods, techniques, drug therapy, and devices in dermatology that provide readers with peer reviewed content of the utmost quality. Our high standards of content are maintained through a balanced, peer-review process. Articles are reviewed by an International Editorial Board of over 160 renowned experts.